Fixed Inclination Humeral Cut | NCT03922763

Studies
Fixed Inclination Humeral Cut

NCT03922763

Sponsor

Rothman Institute Orthopaedics

Status

Unknown status

Last Update Posted

Apr 22, 2019Actual

Enrollment

100Estimated

Phase

Not Applicable

Conditions

Shoulder Osteoarthritis

Interventions

Anatomical cut
Cutting guide

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2019

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Enrolling by invitation

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2, 2019Actual

Primary Completion Date

Feb 2, 2020Estimated

Completion Date

May 2, 2020Estimated

First Submitted Date

Apr 17, 2019

First Submission Date that Met QC Criteria

Apr 19, 2019

First Posted Date

Apr 22, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 19, 2019

Last Update Posted Date

Apr 22, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of the present study is to determine if a standard humeral cut using a fixed neck shaft angled prosthesis for patients undergoing anatomic TSA is able to restore normal glenohumeral relationships as compared to a variable neck shaft angle prosthesis.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Anatomically-matched cut	Active Comparator		Procedure: Anatomical cut
Cutting guide	Active Comparator		Procedure: Cutting guide

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Anatomical cut	Procedure	Surgeon-derived cut based on patient's anatomy	Anatomically-matched cut

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Radriographic measurements	x-rays will be measured by 3 independent surgeons to measure restoration to natural anatomy following total shoulder replacement	x-rays taken day of surgery

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

patients 18 years or older
primary glenohumeral osteoarthritis
intact rotator cuff
primary anatomic shoulder arthroplasty

Exclusion Criteria:

revision arthroplasty
reverse shoulder arthroplasty candidates
cognitive or behavioral problems which would preclude informed consent

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Rothman Institute		Philadelphia	Pennsylvania	19107	United States